Atomoxetine (Page 5 of 11)

Adult Clinical Trials

Reasons for discontinuation of treatment due to adverse reactions in acute adult placebo-controlled trials

In the acute adult placebo-controlled trials, 11.3% (61/541) atomoxetine subjects and 3.0% (12/405) placebo subjects discontinued for adverse reactions. Among atomoxetine hydrochloride-treated patients, insomnia (0.9%, N=5); nausea (0.9%, N=5); chest pain (0.6%, N=3); fatigue (0.6%, N=3); anxiety (0.4%, N=2); erectile dysfunction (0.4%, N=2); mood swings (0.4%, N=2); nervousness (0.4%, N=2); palpitations (0.4%, N=2); and urinary retention (0.4%, N=2) were the reasons for discontinuation reported by more than 1 patient.

Seizures

Atomoxetine hydrochloride has not been systematically evaluated in adult patients with a seizure disorder as these patients were excluded from clinical studies during the product’s premarket testing. In the clinical development program, seizures were reported on 0.1% (1/748) of adult patients. In these clinical trials, no poor metabolizers (0/43) reported seizures compared to 0.1% (1/705) for extensive metabolizers.

Commonly observed adverse reactions in acute adult placebo-controlled trials

Commonly observed adverse reactions associated with the use of atomoxetine hydrochloride (incidence of 2% or greater) and not observed at an equivalent incidence among placebo-treated patients (atomoxetine hydrochloride incidence greater than placebo) are listed in Table 4. The most commonly observed adverse reactions in patients treated with atomoxetine hydrochloride (incidence of 5% or greater and at least twice the incidence in placebo patients) were: constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation (see Table 4).

Additional data from ADHD clinical trials (controlled and uncontrolled) has shown that approximately 5 to 10% of adult patients experienced potentially clinically important changes in heart rate (≥20 beats per min) or blood pressure (≥15 to 20 mm Hg) [see Contraindications (4) and Warnings and Precautions (5) ].

Table 4: Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine Hydrochloride in Acute (up to 25 weeks) Adult Trials

Adverse Reactiona

Percentage of Patients Reporting Reaction

System Organ Class/Adverse Reaction

Atomoxetine Hydrochloride (N=1697)

Placebo(N=1560)

Cardiac Disorders

Palpitations

3

1

Gastrointestinal Disorders

Dry mouth

20

5

Nausea

26

6

Constipation

8

3

Abdominal painb

7

4

Dyspepsia

4

2

Vomiting

4

2

General Disorders and Administration Site Conditions

Fatigue

10

6

Chills

3

0

Feeling jittery

2

1

Irritability

5

3

Thirst

2

1

Investigations

Weight decreased

2

1

Metabolism and Nutritional Disorders

Decreased appetite

16

3

Nervous System Disorders

Dizziness

8

3

Somnolencec

8

5

Paraesthesia

3

0

Psychiatric Disorders

Abnormal dreams

4

3

Insomniad

15

8

Libido decreased

3

1

Sleep disorder

3

1

Renal and Urinary Disorders

Urinary hesitatione

6

1

Dysuria

2

0

Reproductive System and Breast Disorders

Erectile dysfunctionf

8

1

Dysmenorrheag

3

2

Ejaculation delayedf and/or ejaculation disorderf

4

1

Skin and Subcutaneous Tissue Disorders

Hyperhidrosis

4

1

Vascular Disorders

Hot flush

3

0

a Reactions reported by at least 2% of patients treated with atomoxetine, and greater than placebo. The following reactions did not meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: peripheral coldness, tachycardia, prostatitis, testicular pain, orgasm abnormal, flatulence, asthenia, feeling cold, muscle spasm, dysgeusia, agitation, restlessness, micturition urgency, pollakiuria, pruritus, urticaria, flushing, tremor, menstruation irregular, rash, and urinary retention. The following reactions were reported by at least 2% of patients treated with atomoxetine, and equal to or less than placebo: anxiety, diarrhea, back pain, headache, and oropharyngeal pain.

b Abdominal pain includes the terms: abdominal pain upper, abdominal pain, stomach discomfort, abdominal discomfort, epigastric discomfort.

c Somnolence includes the terms: sedation, somnolence.

d Insomnia includes the terms: insomnia, initial insomnia, middle insomnia, and terminal insomnia.

e Based on total number of males (atomoxetine hydrochloride, N=943; placebo, N=869).

f Based on total number of females (atomoxetine hydrochloride, N=754; placebo, N=691).

The following adverse events occurred in at least 2% of adult CYP2D6 poor metaboliser (PM) patients and were statistically significantly more frequent in PM patients compared to CYP2D6 extensive metaboliser (EM) patients: vision blurred (4% of PMs, 1% of EMs); dry mouth (35% of PMs, 17% of EMs); constipation (11% of PMs, 7% of EMs); feeling jittery (5% of PMs, 2% of EMs); decreased appetite (23% of PMs, 15% of EMs); tremor (5% of PMs, 1% of EMs); insomnia (19% of PMs, 11% of EMs); sleep disorder (7% of PMs, 3% of EMs); middle insomnia (5% of PMs, 3% of EMs); terminal insomnia (3% of PMs, 1% of EMs); urinary retention (6% of PMs, 1% of EMs); erectile dysfunction (21% of PMs, 9% of EMs); ejaculation disorder (6% of PMs, 2% of EMs); hyperhidrosis (15% of PMs, 7% of EMs); peripheral coldness (3% of PMs, 1% of EMs).

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